The sterilization of medical instruments is an important factor in preventing infection and the spread of disease. In this regard, specialized sterilization containers have been developed to facilitate sterilization and the storage of sterilized articles in such a manner that their sterilized state is maintained during storage. These containers generally permit entry of the sterilizing medium into the container during the sterilization process, but prevent the entry of airborne contaminants once closed.
In order to provide evidence that the contents of a container have been through a proper sterilization cycle, a removable or permanent tag, tape, label or other device is frequently provided on the exterior of the container. The label or other device may include an ink or other indicator which changes in appearance to demonstrate exposure to conditions sufficient to effect proper sterilization of the container contents. Thus, the intention of these devices is to provide assurances that, when the device on a container has changed in appearance, the container has gone through a proper sterilization cycle. This purpose is easily circumvented, however, simply by processing the device through a sterilization cycle prior to placing it on a container, giving the appearance that the entire container has been through the sterilization cycle.
Another deficiency in the use of these devices stems from the fact that, once the sterilization process has been completed, containers containing sterilized articles are frequently stored for relatively long periods of time before the articles are needed. During this storage period, there is a possibility that the container will be opened, causing contamination of the articles, and then subsequently reclosed. Such unauthorized opening of the container is not readily revealed by visual inspection, and could lead to the use of articles that are no longer sterile or that, perhaps, were never sterilized. Thus, while indicator devices potentially may show that a particular container has been subjected to a sterilization process sufficient to sterilize the articles contained therein, they cannot provide evidence as to whether the articles have become contaminated at any time subsequent to sterilization.
In order to provide evidence of the sterile integrity of the contents of these containers once a sterilization procedure has been completed, various devices have been developed which provide a visual indication that the container may have been opened. Typically, these devices include a seal which must be destroyed to unlock the locking mechanism which enables the container to be opened. Therefore, it can be assumed that, for any container having a broken or missing seal, the contents of the container are no longer sterile. Many of these devices, however, simply prevent the container from being opened, but provide no positive indication as to whether the container has been subjected to a complete sterilization process. Other devices may visually indicate that sterilization has taken place, but provide no region for inscribing data relative to the container and its contents. As a result, the use of these devices frequently requires additional elements to be used to record data relative to the container and/or to indicate that the container has been subjected to a sterilization process.
There therefore exists a need for a security device that enables the recordation of data relative to the contents of the container or other relevant data, that provides a reliable visual indication that the container has been subjected to a sterilization process, and that also reliably reveals whether the container has been opened subsequent to the sterilization process.